FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
by Hartley Medical Center Pharmacy, Incorporated
- Reason
- Lack of Assurance of Sterility
- Published
- March 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4.
by Sun Pharma Global Fze
- Reason
- Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.
- Published
- March 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654
by J. Strickland and Co
- Reason
- Subpotent Drug: failed at the 3 and 6 month stability time points.
- Published
- March 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
by Teva North America
- Reason
- Failed Dissolution Specifications: low test results at the 18 month time-point
- Published
- March 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
by Baxter Healthcare Corp.
- Reason
- PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
- Published
- March 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.
by Genzyme Corporation
- Reason
- Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- Published
- March 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
by Genzyme Corporation
- Reason
- Presence of Particulate Matter: Glass particles found in the product after reconstitution.
- Published
- March 9, 2016
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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